Abstract

Drug losses and theft from the healthcare system are accelerating; hospitals are pressured to implement safeguards to prevent drug diversion. Thus far, no reviews summarize all known risks and potential safeguards for hospital diversion. Past incidents of hospital drug diversion have impacted patient and staff safety, increased hospital costs, and resulted in infectious disease outbreaks. We searched MEDLINE, Embase, PsycINFO, CINAHL, Scopus, and Web of Science databases and the gray literature for articles published between January 2005 and June 2018. Articles were included if they focused on hospital settings and discussed either: (1) drug security or accounting practices (any drug) or (2) medication errors, healthcare worker substance use disorder, or incident reports (only with reference to controlled drugs). We included 312 articles and extracted four categories of data: (1) article characteristics (eg, author location), (2) article focus (eg, clinical areas discussed), (3) contributors to diversion (eg, factors enabling drug theft), and (4) diversion safeguards. Literature reveals a large number of contributors to drug diversion in all stages of the medication-use process. All health professions and clinical units are at risk. This review provides insights into known methods of diversion and the safeguards hospitals must consider to prevent them. Careful configuration of healthcare technologies and processes in the hospital environment can reduce the opportunity for diversion. These system-based strategies broaden the response to diversion beyond that of individual accountability. Further evidence is urgently needed to address the vulnerabilities outlined in this review and prevent harm.

The United States (US) and Canada are the two highest per-capita consumers of opioids in the world;1 both are struggling with unprecedented opioid-related mortality.2,3 The nonmedical use of opioids is facilitated by diversion and defined as the transfer of drugs from lawful to unlawful channels of use4,5 (eg, sharing legitimate prescriptions with family and friends6). Opioids and other controlled drugs are also diverted from healthcare facilities;4,5,7,8 Canadian data suggest these incidents may be increasing (controlled-drug loss reports have doubled each year since 20159).

The diversion of controlled drugs from hospitals affects patients, healthcare workers (HCWs), hospitals, and the public. Patients suffer insufficient analgesia or anesthesia, experience substandard care from impaired HCWs, and are at risk of infections from compromised syringes.4,10,11 HCWs that divert are at risk of overdose and death; they also face regulatory censure, criminal prosecution, and civil malpractice suits.12,13 Hospitals bear the cost of diverted drugs,14,15 internal investigations,4 and follow-up care for affected patients,4,13 and can be fined in excess of $4 million dollars for inadequate safeguards.16 Negative publicity highlights hospitals failing to self-regulate and report when diversion occurs, compromising public trust.17-19 Finally, diverted drugs impact population health by contributing to drug misuse.

Hospitals face a critical problem: how does a hospital prevent the diversion of controlled drugs? Hospitals have not yet implemented safeguards needed to detect or understand how diversion occurs. For example, 79% of Canadian hospital controlled-drug loss reports are “unexplained losses,”9 demonstrating a lack of traceability needed to understand the root causes of the loss. A single US endoscopy clinic showed that $10,000 of propofol was unaccounted for over a four-week period.14 Although transactional discrepancies do not equate to diversion, they are a potential signal of diversion and highlight areas for improvement.15 The hospital medication-use process (MUP; eg, procurement, storage, preparation, prescription, dispensing, administration, waste, return, and removal) has multiple vulnerabilities that have been exploited. Published accounts of diversion include falsification of clinical documents, substitution of saline for medication, and theft.4,20-23 Hospitals require guidance to assess their drug processes against known vulnerabilities and identify safeguards that may improve their capacity to prevent or detect diversion.

In this work, we provide a scoping review on the emerging topic of drug diversion to support hospitals. Scoping reviews can be a “preliminary attempt to provide an overview of existing literature that identifies areas where more research might be required.”24 Past literature has identified sources of drugs for nonmedical use,6,25,26 provided partial data on the quantities of stolen drug,7,8 and estimated the rate of HCW diversion.5,27-29 However, no reviews have focused on system gaps specific to hospital MUPs and diversion. Our review remedies this knowledge gap by consolidating known weaknesses and safeguards from peer- and nonpeer-reviewed articles. Drug diversion has been discussed at conferences and in news articles, case studies, and legal reports; excluding such discussion ignores substantive work that informs diversion practices in hospitals. Early indications suggest that hospitals have not yet implemented safeguards to properly identify when diversion has occurred, and consequently, lack the evidence to contribute to peer-reviewed literature. This article summarizes (1) clinical units, health professions, and stages of the MUP discussed, (2) contributors to diversion in hospitals, and (3) safeguards to prevent or detect diversion in hospitals.

METHODS

Scoping Review

We followed Arksey and O’Malley’s six-step framework for scoping reviews,30 with the exception of the optional consultation phase (step 6). We addressed three questions (step 1): what clinical units, health professions, or stages of the medication-use process are commonly discussed; what are the identified contributors to diversion in hospitals; and what safeguards have been described for prevention or detection of diversion in hospitals? We then identified relevant studies (step 2) by searching records published from January 2005 to June 2018 in MEDLINE, Embase, PsycINFO, CINAHL, Scopus, and Web of Science; the gray literature was also searched (see supplementary material for search terms).

All study designs were considered, including quantitative and qualitative methods, such as experiments, chart reviews and audit reports, surveys, focus groups, outbreak investigations, and literature reviews. Records were included (step 3) if abstracts met the Boolean logic criteria outlined in Appendix 1. If no abstract was available, then the full-text article was assessed. Prior to abstract screening, four reviewers (including R.R.) independently screened batches of 50 abstracts at a time to iteratively assess interrater reliability (IRR). Disagreements were resolved by consensus and the eligibility criteria were refined until IRR was achieved (Fleiss kappa > 0.65). Once IRR was achieved, the reviewers applied the criteria independently. For each eligible abstract, the full text was retrieved and assigned to a reviewer for independent assessment of eligibility. The abstract was reviewed if the full-text article was not available. Only articles published in English were included.

Reviewers charted findings from the full-text records (steps 4 and 5) by using themes defined a priori, specifically literature characteristics (eg, authors, year of publication), characteristics related to study method (eg, article type), variables related to our research questions (eg, variations by clinical unit, health profession), contributors to diversion, and safeguards to detect or prevent diversion. Inductive additions or modifications to the themes were proposed during the full-text review (eg, reviewers added a theme “name of drugs diverted” to identify drugs frequently reported as diverted) and accepted by consensus among the reviewers.

RESULTS

Scoping Review

The literature search generated 4,733 records of which 307 were duplicates and 4,009 were excluded on the basis of the eligibility criteria. The reviewers achieved 100% interrater agreement on the fourth round of abstract screening. Upon full-text review, 312 articles were included for data abstraction (Figure).

Literature Characteristics

Table 1 summarizes the characteristics of the included literature. The articles were published in a mix of peer-reviewed (137, 44%) and nonpeer-reviewed (175, 56%) sources. Some peer-reviewed articles did not use research methods, and some nonpeer-reviewed articles used research methods (eg, doctoral theses). Therefore, Table 1 categorizes the articles by research method (if applicable) and by peer-review status. The articles primarily originated in the United States (211, 68%) followed by Canada (79, 25%) and other countries (22, 7%). Most articles were commentaries, editorials, reports or news media, rather than formal studies presenting original data.

Most articles did not focus the discussion on any one clinical unit, health profession, or stage of the MUP. Of the articles that made explicit mention of clinical units, hospital pharmacies and operating rooms were discussed most often, nurses were the most frequently highlighted health profession, and most stages of the MUP were discussed equally, with the exception of prescribing which was mentioned the least (Supplementary Table).

Contributors to Diversion

The literature describes a variety of contributors to drug diversion. Table 2 organizes these contributors by stage of the MUP and provides references for further discussion.

The diverse and system-wide contributors to diversion described in Table 2 support inappropriate access to controlled drugs and can delay the detection of diversion after it occurred. These contributors are more likely to occur in organizations that fail to adhere to drug-handling practices or to carefully review practices.34,44

Diversion Safeguards in Hospitals

Table 3 summarizes published recommendations to mitigate the risk of diversion by stage of the MUP.

DISCUSSION

This review synthesizes a broad sample of peer- and nonpeer-reviewed literature to produce a consolidated list of known contributors (Table 2) and safeguards against (Table 3) controlled-drug diversion in hospitals. The literature describes an extensive list of ways drugs have been diverted in all stages of the MUP and can be exploited by all health professions in any clinical unit. Hospitals should be aware that nonclinical HCWs may also be at risk (eg, shipping and receiving personnel may handle drug shipments or returns, housekeeping may encounter partially filled vials in patient rooms). Patients and their families may also use some of the methods described in Table 2 (eg, acquiring fentanyl patches from unsecured waste receptacles and tampering with unsecured intravenous infusions).

Given the established presence of drug diversion in the literature,5,7-9,96,97 hospitals should assess their clinical practices against these findings, review the associated references, and refer to existing guidance to better understand the intricacies of the topic.7,31,51,53,60,79 To accommodate variability in practice between hospitals, we suggest considering two underlying issues that recur in Tables 2 and 3 that will allow hospitals to systematically analyze their unique practices for each stage of the MUP.

The first issue is falsification of clinical or inventory documentation. Falsified documents give the opportunity and appearance of legitimate drug transactions, obscure drug diversion, or create opportunities to collect additional drugs. Clinical documentation can be falsified actively (eg, deliberately falsifying verbal orders, falsifying drug amounts administered or wasted, and artificially increasing patients’ pain scores) or passively (eg, profiled automated dispensing cabinets [ADC] allow drug withdrawals for a patient that has been discharged or transferred over 72 hours ago because the system has not yet been updated).

Falsification of inventory documentation can involve deliberate miscounting of drug inventory, removing records of drug procurement and intercepting the shipment when it arrives, and forging signatures on drug deliveries from the pharmacy to the care unit. Prevention safeguards include constraining clinical choices, decreasing delays to documentation updates, increasing traceability, and improving verification of transactions. For example, standardizing ordering protocols constrains clinical choices so that minimal controlled drug is dispensed, leading to reduced risk of dispensing more than the patient needs (eg, order sets that avoid dose ranges or limit as needed [PRN] doses). An example of decreasing delays to documentation updates are ADC profiles that rapidly remove discharged patients, so that it is not possible to dispense drugs for a transferred patient. Examples of increasing traceability include biometric (eg, fingerprint) signatures or using cameras in select areas which deter forgery and support auditing. Verification of the transactions listed in the documentation has typically relied upon a real-time witness, but may not always be possible. For example, it is infeasible to require a witness to verify all drug administration to patients. Therefore, future work may be needed to develop other strategies to verify physical transactions (eg, weight sensors and computer vision). Detection safeguards for documentation rely on auditing, therefore electronic systems can be an important asset to employ. For example, electronic systems support monitoring of unusual trends (eg, prescribing activity by care unit or HCW; number of unverified verbal orders; dispensing activity by ADC, care unit, drug, or HCW; variations in patient pain scores between HCWs; drug wastage amounts). If data from multiple systems can be integrated (eg, electronic health records and ADCs), then hospitals can more easily identify discrepancies among the drug amount ordered, dispensed, administered, and wasted or disposed for each patient. Hospitals can also compare purchased inventory against financial records to identify discrepancies. Clinical outcomes can also highlight potential drug discrepancies (eg, uncontrolled pain could be a signal for partial or absent administration of drugs).

The second issue involves failure to maintain the physical security of controlled drugs, thereby allowing unauthorized access. This issue includes failing to physically secure drug stock (eg, propping doors open to controlled-drug areas; failing to log out of ADCs, thereby facilitating unauthorized access; and leaving prepared drugs unsupervised in patient care areas) or failing to maintain accurate access credentials (eg, staff no longer working on the care unit still have access to the ADC or other secure areas). Prevention safeguards require adherence to existing security protocols (eg, locked doors and staff access frequently updated) and limiting the amount of controlled drugs that can be accessed (eg, supply on care unit should be minimized to what is needed and purchase smallest unit doses to minimize excess drug available to HCWs). Hospitals may need to consider if security measures are actually feasible for HCWs. For example, syringes of prepared drugs should not be left unsupervised to prevent risk of substitution or tampering; however, if the responsible HCW is also expected to collect supplies from outside the care area, they cannot be expected to maintain constant supervision. Detection safeguards include the use of tamper-evident packaging to support detection of compromised controlled drugs or assaying drug waste or other suspicious drug containers to detect dilution or tampering. Hospitals may also consider monitoring whether staff access controlled-drug areas when they are not scheduled to work to detect security breaches.

Safeguards for both issues benefit from an organizational culture reinforced through training at orientation and annually thereafter. Staff should be aware of reporting mechanisms (eg, anonymous hotlines), employee and professional assistance programs, self-reporting protocols, and treatment and rehabilitation options.10,12,29,47,72,91 Other system-wide safeguards described in Table 3 should also be considered. Detection of transactional discrepancies does not automatically indicate diversion, but recurrent discrepancies indicate a weakness in controlled-drug management and should be rectified; diversion prevention is a responsibility of all departments, not just the pharmacy.

Hospitals have several motivations to actively invest in safeguards. Drug diversion is a patient safety issue, a patient privacy issue (eg, patient records are inappropriately accessed to identify opportunities for diversion), an occupational health issue given the higher risks of opioid-related SUD faced by HCWs, a regulatory compliance issue, and a legal issue.31,41,46,59,78,98,99 Although individuals are accountable for drug diversion itself, hospitals should take adequate measures to prevent or detect diversion and protect patients and staff from associated harms. Hospitals should pay careful attention to the configuration of healthcare technologies, environments, and processes in their institution to reduce the opportunity for diversion.

Our study has several limitations. We did not include articles prior to 2005 because we captured a sizable amount of literature with the current search terms and wanted the majority of the studies to reflect workflow based on electronic health records and medication ordering, which only came into wide use in the past 15 years. Other possible contributors and safeguards against drug diversion may not be captured in our review. Nevertheless, thorough consideration of the two underlying issues described will help protect hospitals against new and emerging methods of diversion. The literature search yielded a paucity of controlled trials formally evaluating the effectiveness of these interventions, so safeguards identified in our review may not represent optimal strategies for responding to drug diversion. Lastly, not all suggestions may be applicable or effective in every institution.

CONCLUSION

Drug diversion in hospitals is a serious and urgent concern that requires immediate attention to mitigate harms. Past incidents of diversion have shown that hospitals have not yet implemented safeguards to fully account for drug losses, with resultant harms to patients, HCWs, hospitals themselves, and the general public. Further research is needed to identify system factors relevant to drug diversion, identify new safeguards, evaluate the effectiveness of known safeguards, and support adoption of best practices by hospitals and regulatory bodies.

Acknowledgments

The authors wish to thank Iveta Lewis and members of the HumanEra team (Carly Warren, Jessica Tomasi, Devika Jain, Maaike deVries, and Betty Chang) for screening and data extraction of the literature and to Peggy Robinson, Sylvia Hyland, and Sonia Pinkney for editing and commentary.

Disclosures

Ms. Reding and Ms. Hyland were employees of North York General Hospital at the time of this work. Dr. Hamilton and Ms. Tscheng are employees of ISMP Canada, a subcontractor to NYGH, during the conduct of the study. Mark Fan and Patricia Trbovich have received honoraria from BD Canada for presenting preliminary study findings at BD sponsored events.

Funding

This work was supported by Becton Dickinson (BD) Canada Inc. (grant #ROR2017-04260JH-NYGH). BD Canada had no involvement in study design; in the collection, analysis or interpretation of data; in the writing of the report; or in the decision to submit the article for publication.